Department of Health and Social Care

Clinical trials consultation response

Lord Markham: My Hon Friend the Minister of State (Minister for Health and Secondary Care) (Will Quince) has made the following written statement: The government has announced plans to overhaul the legislation that governs clinical trials, to introduce a series of measures to make it faster and easier to run clinical trials in the UK. These changes will help speed up clinical trials, without compromising on safety, and encourage the development of new and better medicines for patients. They come after the government announced an extra £10 million of additional funding for the Medicines and Healthcare products Regulatory Agency (MHRA) to accelerate the delivery of cutting-edge treatments, including cancer vaccines. Leaving the European Union has provided a unique opportunity for the United Kingdom to improve regulatory regimes for healthcare products and exercise our new powers as a sovereign regulator. The Medicines and Medical Devices Act 2021 allows us to update the current legislation for clinical trials, creating a world-leading regime that prioritises patient safety while enabling and encouraging innovation within the clinical research environment. To deliver this ambition and gather views of patients, industry and academia, we published a consultation on the future of UK regulations for clinical trials (Consultation on proposals for legislative changes for clinical trials - GOV.UK (www.gov.uk)) on 17 January 2022. We received 2138 responses and I am grateful to all those who have taken the time to respond to the consultation. Officials at the MHRA, in collaboration with the Health Research Authority (HRA), have analysed the consultation responses and have worked with officials within my Department and the Office of Life Sciences to develop the Government response. The response outlines changes that will support innovation within the UK’s life sciences sector and patient access to potentially life-saving medicines, for example through enhancing the transparency of clinical trials; enabling greater proportionality and streamlining the approvals process. We are removing granular and duplicative regulatory requirements, moving away from ‘one size fits all’ regulation and embedding principles of proportionality. Ensuring that the regulatory requirements expected are more flexible to match the risk that a trial presents, will result in a regulatory framework that is responsive to all kinds of trials and adaptable to innovative research. The changes also formalise the Combined Review process in legislation, ensuring research teams receive a single decision from both regulatory and ethical reviews, done in parallel between the MHRA and HRA. This reflects the UK Government’s intention to embrace innovation in clinical trials and accelerate the evaluation and implementation of advances in medical interventions to the benefit of UK patients everywhere. The legislative changes outlined in the consultation response provide firm foundation for and align with the review of clinical trials led by Lord O’Shaughnessy and work undertaken by Sir Patrick Vallance, to ensure a pro-innovation regulatory environment. Through this collective work we will cement our status as a science superpower by making the UK the best place in the world to conduct fast, efficient and cutting-edge clinical research. The government’s response to the consultation will be published on GOV.UK today.

Cabinet Office

Update on procurement exclusion

Baroness Neville-Rolfe: My Rt Hon Friend the Minister for the Cabinet Office and HM Paymaster General, Jeremy Quin MP, has today made the following statement:In August 2022, Bain & Company and its global affiliates were excluded from bidding for UK Government business. Following the decision, Bain & Company have cooperated with our investigations, and have provided considerable additional information on their self-cleansing actions. They have also agreed to a period of rigorous monitoring for a minimum of two years, during which their continued compliance will be assessed. Given the progress made since the exclusion, we can confirm that while Bain & Company South Africa, Inc. will remain excluded from UK Government business, Bain & Company, Inc. and its affiliates outside of South Africa are no longer excluded from bidding for government work.Following robust and intensive dialogue with Bain & Company since the exclusion decision was made in August, which has received the full cooperation from the company, we have concluded that Bain & Company, Inc. and its affiliates outside of South Africa, including both Bain & Company, Inc. United Kingdom and BuyingTeam Limited (trading as Proxima), can bid for UK Government work.Since the exclusion decision in August 2022, Bain & Company have responded by producing detailed evidence of the measures they have taken internally (including related to the way Bain & Company handles bids for UK Government work), which was not available to the Cabinet Office previously.This decision is subject to a regular and thorough period of close monitoring, for a minimum of two years, so we can be satisfied that the company continues to uphold the measures they have now put in place.During the monitoring period, Bain & Company has agreed that it will engage further with the Cabinet Office to provide evidence that their governance, organisation and internal processes are now working and will continue to work as they should do to prevent anything similar happening again.Bain & Company South Africa, Inc. remains excluded from bidding for UK Government procurements until 4 January 2025, given the findings of the Zondo Commission on its prior involvement with the South African Revenue Service. Bain & Company South Africa has acknowledged it did not fully clarify the facts and circumstances regarding its work for the South African Revenue Service in a comprehensive manner.Bain & Company has previously apologised for the fact that Bain & Company South Africa’s work in South Africa contributed to damaging a critical public institution and acknowledged that its cooperation with investigating authorities fell short.We will review any new information that comes to light, including as a result of any potential reconsideration by the South African Government of their decision to ban Bain & Company South Africa.Bain & Company has welcomed this robust external challenge, to help ensure that going forward their governance is of a consistently high standard, that the self-cleansing actions put in place are operational and that any new issues arising are being managed and communicated transparently.We strongly condemn corporate malpractice and will not hesitate to exclude suppliers should they be found to not be upholding the highest standards.

Publication of the Fraud Landscape Report

Baroness Neville-Rolfe: My Rt Hon Friend the Minister for the Cabinet Office and HM Paymaster General, Jeremy Quin MP, has today made the following statement:Today the Government is publishing the 2020-21 Fraud Landscape Report. This follows the establishment of the new Public Sector Fraud Authority (PSFA) in August last year to raise the government’s ambition across the public sector in understanding risks and reducing fraud.The report continues to push the government's transparency agenda by publishing data on the level of detected and estimated fraud and error in the public sector. This report estimates fraud and error losses for central government (excluding those relating to tax and welfare, which are published separately by HMRC and DWP).In 2020-2021, fraud detection figures grew by 7% on the previous year with departments and public bodies detecting £243 million of fraud, in line with government's objective to continue to focus on the identification and reduction in fraud. These figures include fraud related to schemes in support of the pandemic.The report shows how the government adjusted the Counter Fraud Function to focus on fraud around the COVID-19 schemes. This was achieved by establishing a COVID-19 intelligence hotline, utilising data analytics and assessing the levels of fraud in all COVID-19 schemes, so that the Centre of Expertise were able to coordinate a unified approach to countering fraud.The government has continued to develop its capability to take action on fraud. There are now 7,011 individuals, from 35 organisations, who are members of the world's first Counter Fraud Profession meeting our target.In 2020/21, an additional 99 counter fraud colleagues from across government were trained in the new discipline of fraud risk assessment. This has helped us to better understand fraud at the commencement of government initiatives, a particularly helpful skill in the wake of the pandemic.This government attaches importance to transparency and the improvements it can bring in fraud detection and prevention right across the public sector. While efforts to support departments and public bodies during the pandemic delayed work on this report, the PSFA intends to publish a bulletin with the data from 2021-2022 in the first half of 2023.

Department for Culture, Media and Sport

Publication of the Tourism Recovery Plan Update Report

Lord Parkinson of Whitley Bay: I am repeating the following Written Ministerial Statement made today in the other place by my Honourable Friend, the Minister for Media, Tourism and Creative Industries, Julia Lopez MP:I am pleased to publish today an Update Report on progress made against the objectives set out in the government’s Tourism Recovery Plan.Tourism is a significant economic, cultural and social asset to the UK. The sector is a powerful engine for economic growth and job creation in every part of the UK. Pre-pandemic it directly employed 1.7 million people, supported 230,000 SMEs and contributed £74 billion in Gross Value Added – 4% of the UK’s total. As an industry with long-term growth prospects (forecast at 3% a year globally to 2030), international reach, and a presence in every constituency, tourism has a major role to play in the Government’s wider Union, levelling up, and Global Britain agendas.The Tourism Recovery Plan was published in 2021 in recognition of the significant impact of the COVID-19 pandemic on the UK’s visitor economy. The Plan set out a framework for joint Government and sector development. In the short to medium term, it set out the ambition to recover pre-pandemic levels of domestic and international visitor volume and spending. In the medium to long term, the remaining objectives focused on supporting the growth of a productive, innovative, resilient, sustainable, and accessible visitor economy that benefits every nation and region of the UK.We are now three years on from the beginning of the COVID-19 pandemic, the first national lockdown and the start of Government support for businesses affected by closures and social distancing measures.This Update Report sets out the progress made against the Plan’s six objectives, highlights ongoing work, and sets out the future actions the Government will take to continue supporting the sector as it not only recovers from the COVID-19 pandemic but also faces the economic challenges that have arisen since the publication of the Plan in 2021.The Report sets out the mixed picture of recovery in the sector. In total, over £37 billion in support through grants, tax relief and loans was provided to the hospitality, leisure and tourism sectors to help them survive through the long periods of uncertainty and adversity. The sector is, however, still facing economic challenges. Domestic tourism is recovering well, but international tourism is lagging behind the targets set in the Plan. Behind this mixed picture of recovery, there is huge long-term potential for economic growth, which is why the Government re-commits in this Report to support the sector through the framework of the Tourism Recovery Plan – to help it grow, thrive and, in turn, boost the UK economy. More broadly, the Prime Minister has promised to halve inflation this year and grow the economy, both of which will support the sector.Overall, the Report indicates that good progress has been made against the objectives of the Tourism Recovery Plan. It acknowledges that there is further to go to support the full recovery of the visitor economy in the short term and to work with industry to deliver on the medium- to long-term ambition to build a more resilient, innovative, sustainable and inclusive sector that benefits every corner of the UK.A copy of the Update Report on the Tourism Recovery Plan will be placed in the Libraries of both Houses.

Department for Transport

Rail reform update

Baroness Vere of Norbiton: My Right Honourable friend, the Secretary of State for Transport (Mark Harper), has made the following Ministerial Statement:Today, I am pleased to provide an update on this Government’s plans to reform our railways. I am announcing the location chosen to be the national headquarters of Great British Railways (GBR), providing further detail on GBR’s regionalised approach including how GBR will benefit the whole of Great Britain, as well as offering more detail on the role of GBR.From a shortlist of six locations announced last summer, Derby has been chosen as the city to be the future headquarters of GBR.Among an exceptional list of shortlisted applicants, Derby scored highest in the Expression of Interest stage of the competition, which analysed its suitability against six published criteria: levelling up, connectivity, opportunities for GBR, value for money, heritage and public support. It also scored highest in the six-week public vote, attracting 45,600 votes, more than 5,000 ahead of the second placed location in a total vote of 205,000.Derby will become the heart of Great Britain’s rail industry, bringing together track and train, as well as revenue and cost. This means we will finally treat the railway as the whole system it should be rather than a web of disparate interests that it’s become. Passengers will no longer face the excuse-making and blame-shifting of years past. Instead, GBR will be wholeheartedly customer-focussed, serving as the single point of accountability for the performance of the railway. The rail campus, led by GBR HQ, will help position the industry to achieve this.GBR will put customers at the heart of its reforms. It will reinvigorate the role of the private sector to help drive innovation with an unrelenting focus on quality, customer service and experience. Under GBR, rail journeys, buying tickets and ticket prices will be easier, simpler and fairer.Whilst GBR’s headquarters will be in Derby, other towns and cities will also benefit from hosting empowered regional GBR hubs equipped with decision making and investment powers aimed at benefiting their local communities. GBR will support jobs spanning across Great Britain including the North, Southeast, Southwest and London. The GBR HQ will share learning, partnerships, connections and opportunities across these centres of excellence.GBR’s Transition Team will now work with Derby to identify the site for the HQ within the city, which will represent value for money for the taxpayer. The Midlands is already a transport supercluster for Britain: with DfT and HS2 based in Birmingham, bringing GBR HQ to Derby represents a further boost to the region’s transport sector and demonstrates our commitment to levelling up the country.